FDA-filed SPL labeling · retrieved through openFDA

Olopatadine

Olopatadine is an antihistamine available as eye drops and nasal spray that relieves itchy, red eyes from allergic conjunctivitis and nasal symptoms from seasonal allergic rhinitis.

Brand names PatadayPatanaseEye Allergy Itch ReliefEye Allergy Itch and Redness ReliefPataday Once Daily Relief +11 more
Drug classes ⓘ Histamine-1 Receptor Antagonist
Rx/OTC Forms 3 Routes Ophthalmic · Nasal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 114 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMar 25, 2024
Clinical labels in scope ⓘ114
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1996
FDA-listed product records ⓘ246
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 20, 2026
Other forms & routes:
Nasal Ophthalmic
⭐ Olopatadine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Olopatadine is a well-established antihistamine that effectively relieves allergy-related eye itching and redness (as eye drops) and seasonal nasal allergy symptoms (as a nasal spray). The eye drop form is generally very well tolerated; the nasal spray can cause drowsiness and occasional nosebleeds, so avoid alcohol and be cautious driving. Always use the product labeled for your route — eye drops are for the eyes only, nasal spray is for the nose only.
How we write & review this content — our editorial policy →

📖 Olopatadine: Patient Information Guide

A plain-language walkthrough of Olopatadine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Olopatadine is used to treat allergy-related eye and nasal symptoms, with the specific conditions depending on the product form and route.

  • Eye drops (including Allergy Relief Eye Drops, CVS Eye Allergy Itch Relief, Equate Olopatadine Hydrochloride Ophthalmic Solution, Eye Allergy Itch and Redness Relief, and Eye Allergy Itch Relief): temporarily relieve itchy eyes — and some products also relieve redness — caused by pollen, ragweed, grass, animal hair, and dander
  • Olopatadine hydrochloride ophthalmic solution 0.2% (prescription): indicated for the treatment of ocular itching associated with allergic conjunctivitis
  • Nasal spray (Patanase and olopatadine hydrochloride nasal spray): indicated for the relief of symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older
⚙️How it works▾

Olopatadine works by blocking H1 histamine receptors — the docking sites that histamine (your body's main allergy chemical) latches onto to trigger itching, redness, sneezing, and a runny nose. By blocking those receptors, olopatadine stops histamine from causing those symptoms. The ophthalmic formulation also acts as a mast cell stabilizer, meaning it helps prevent allergy cells in the eye from releasing histamine in the first place — giving it a dual action in the eye.

💊How it's taken▾

How you take olopatadine depends entirely on the form and the specific product. Eye drops are placed directly into the eye and used either once or twice daily depending on the product — always check your label. The nasal spray is used in both nostrils twice daily; adults and adolescents use a higher number of sprays per nostril than children ages 6 to 11. The nasal spray must be primed before first use and re-primed after more than 7 days without use.

  • Eye drops: 1 drop per affected eye, once or twice daily depending on product — no more than the labeled maximum per day
  • Nasal spray: twice daily into each nostril — number of sprays per nostril varies by age; follow your prescriber's guidance
  • If you miss a dose, take it as soon as you remember, but do not double up — follow your prescriber's or label's instructions
🤒Side effects — in detail▾

The most commonly reported side effects vary by form. With the nasal spray, the most frequent include:

  • Bitter taste (very common, especially in adults)
  • Headache
  • Nosebleeds (epistaxis)
  • Sore or irritated throat (pharyngolaryngeal pain)
  • Post-nasal drip
  • Cough
  • Drowsiness
  • Upper respiratory tract infections (more common in children 6–11)

With eye drops, common effects may include temporary eye irritation or discomfort. Stop using the eye drops and contact your doctor right away if you experience eye pain, changes in vision, worsening redness, or itching that persists beyond 72 hours — these could signal a more serious problem.

⚠️Warnings & precautions▾
  • Nosebleeds and nasal sores: The nasal spray can cause nosebleeds and, in some cases, ulcers (sores) inside the nose. Your doctor should check your nose before and during treatment. Stop the spray and call your doctor if you develop nasal sores. People with nasal conditions other than seasonal allergic rhinitis should not use it.
  • Drowsiness and impaired alertness: The nasal spray can make you drowsy. Do not drive, use heavy machinery, or do tasks requiring full concentration until you know how it affects you.
  • Alcohol and sedating medications: Combining the nasal spray with alcohol or other CNS depressants can make drowsiness significantly worse.
  • Depression: In long-term safety studies, depression or worsening of existing depression was reported in some patients using the nasal spray — including some who needed hospitalization. Tell your doctor if you have a history of depression.
  • Eye drops — for external use only: Do not inject or swallow eye drops. If swallowed, contact a Poison Control Center immediately.
🔀What it interacts with▾

Olopatadine has few significant drug interactions, but there are important things to avoid with the nasal spray in particular.

  • Alcohol: Increases drowsiness and impairs alertness — avoid while using the nasal spray
  • CNS depressants (such as sedatives, sleep aids, or anti-anxiety medications): Can compound the drowsiness caused by the nasal spray — use with caution or avoid
  • Liver enzyme inhibitors and protein-bound drugs: No significant interactions are expected because olopatadine is mainly cleared by the kidneys, not broken down by liver enzymes

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to olopatadine: Do not use if you are allergic to olopatadine or any ingredient in the product
  • Contact lens wearers: Remove lenses before using eye drops; wait at least 10 minutes before reinserting; do not wear contacts if your eye is red; do not use eye drops for irritation caused by contact lenses
  • Nasal conditions: Tell your doctor if you have any nasal condition beyond seasonal allergic rhinitis before starting the nasal spray
  • Pregnancy: No human data specific to olopatadine nasal spray exist; animal studies at very high doses showed risks. Discuss with your doctor before using if you are pregnant.
  • Breastfeeding: It is unknown whether olopatadine from the nasal spray passes into human breast milk. Talk to your doctor about the risks and benefits.
  • Children under 6: Safety and effectiveness of the nasal spray have not been established in children younger than 6 years
  • Children under 2: Eye drops should not be used in children under 2 without a doctor's direction
  • Older adults (65+): Use the nasal spray cautiously — age-related changes in kidney, liver, or heart function may affect how olopatadine is processed
  • History of depression: Tell your doctor before starting the nasal spray if you have a personal or family history of depression
🚑If you take too much▾

If too much olopatadine is taken, symptoms may include drowsiness in both adults and children; in children, agitation or restlessness may appear before drowsiness sets in. There is no specific antidote. If you suspect an overdose or someone swallows the eye drops, call Poison Control right away at 1-800-222-1222 or seek emergency medical care.

📡Pharmacodynamics — effects in the body▾

In a cardiovascular safety study using oral olopatadine at doses 8 times higher than the recommended nasal dose, no meaningful effect on the heart's electrical rhythm (QT interval) was seen compared to placebo. In a separate 12-month study of the nasal spray at the recommended dose, no QT prolongation was observed. These findings suggest that olopatadine at normal therapeutic doses does not significantly affect heart rhythm.

🔬Pharmacokinetics — how your body processes it▾

When used as a nasal spray, olopatadine is absorbed fairly quickly, with blood levels peaking within 15 minutes to 2 hours. About 57% of the nasal dose reaches the bloodstream. The drug stays in the body for a moderate length of time, with a half-life (the time for blood levels to fall by half) of 8 to 12 hours — which is why it is dosed twice daily. Olopatadine is not heavily broken down by the liver; roughly 70% leaves the body unchanged through the urine, making kidney function more important than liver function for its clearance.

📦How to store it▾

Storage: Store at 39°F-77°F (4°C-25°C) Manufactured by: Manufactured for: Wintac Limited Somerset Therapeutics, LLC Bangalore 562123 Mendham, NJ 07945 India.

📄 Written from Olopatadine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Olopatadine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does olopatadine treat — is it just for eyes, or can it help my runny nose too? ▾
It does both, but with different products. The eye drops are for allergy-related itchy and red eyes. The nasal spray — brands like Patanase — is for seasonal allergic rhinitis, meaning the sneezing, congestion, and runny nose you get during allergy season. You'd need to use the right form for the right problem, and they're not interchangeable — eye drops go in the eye, the nasal spray goes in the nose only.
Can I wear my contact lenses while using olopatadine eye drops? ▾
You need to take your contacts out before you put the drops in. Wait at least 10 minutes after using the drops before you put them back in. Also, don't wear contacts at all if your eye is red — and these drops aren't meant to treat contact lens-related irritation, so if your eye is bothering you because of your lenses, that's a separate issue to discuss with your eye doctor.
Will the nasal spray make me drowsy? I drive to work every morning. ▾
It can cause drowsiness in some people. The label specifically warns against driving or operating machinery until you know how it affects you. It's a good idea to try your first dose at a time when you don't need to drive, just to see how you feel. And steer clear of alcohol or any sleep aids while you're using it — those combinations make the drowsiness noticeably worse.
I've been getting nosebleeds since I started the nasal spray. Is that normal? Should I stop? ▾
Nosebleeds are one of the more common side effects of the nasal spray, and they were reported in clinical trials too. Occasional nosebleeds are generally not a reason to stop right away, but you should mention it to your doctor at your next visit. If you notice sores inside your nose or the nosebleeds are frequent or severe, contact your doctor — they may want to examine your nasal passages and decide whether to continue the spray.
Is it safe to use the nasal spray if I'm pregnant or breastfeeding? ▾
There aren't good human studies on olopatadine nasal spray in pregnancy specifically. Animal studies using very high oral doses did show some concerns, though those doses were far above what you'd get from a nasal spray. For breastfeeding, it's unknown whether olopatadine passes into human breast milk from the nasal route. The bottom line: talk to your doctor before using it — they can weigh the benefits of controlling your allergies against any potential risks for you and your baby.
My 4-year-old has terrible seasonal allergies. Can she use the nasal spray? ▾
Unfortunately, the nasal spray hasn't been proven safe and effective for children under 6, so it's not recommended for a 4-year-old. For the eye drops, children 2 and older can use them, but anything under 2 needs a doctor's okay first. Talk to your child's pediatrician about what allergy options are appropriate for her age.
Is Olopatadine available over the counter? ▾
Both — Olopatadine is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Olopatadine first available? ▾
Olopatadine has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Olopatadine? ▾
Olopatadine is supplied by 74 manufacturers listed in the FDA NDC Directory, including Dr. Reddy's Laboratories Inc., Apotex Corp., A-S Medication Solutions.

💬 Answers drafted from Olopatadine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Olopatadine comes

Olopatadine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Eye drops

In the eye
Brands Allergy Relief Eye Drops CVS Eye Allergy Itch Relief Eye Allergy Itch and Redness Relief Eye Allergy Itch Relief Leader Olopatadine Hydrochloride Leader Olopatadine Hydrochloride Ophthalmic Solution Once Daily Relief Pataday Once Daily Relief Pataday Twice A Day Relief Retaine Allergy
How this form is used
What it may be used for
  • Allergy Relief Eye Drops, Eye Allergy Itch Relief, CVS Eye Allergy Itch Relief, and Equate Olopatadine Hydrochloride Ophthalmic Solution temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander
  • Eye Allergy Itch and Redness Relief and CVS Eye Allergy Itch Relief also temporarily relieve red eyes from the same allergens
  • Olopatadine hydrochloride ophthalmic solution 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis
Important instructions
  • Adults and children 2 years and older: place 1 drop in the affected eye(s) — either once daily (no more than once per day) or twice daily every 6 to 8 hours depending on the specific product; follow the directions on your product label
  • If you use other eye drops at the same time, wait at least 5 minutes between products
  • Remove contact lenses before use; wait at least 10 minutes before reinserting them; do not wear contacts if your eye is red
  • Do not touch the tip of the container to any surface; replace the cap after each use; children under 2 years of age should not use without a doctor's guidance
Available strengths 5 strengths
1 mg/mL 1.11 mg/mL 2 mg/mL 5 mg/2.5 mL 7 mg/mL
206 FDA-listed product records ⓘ

Nasal spray

In the nose
Brands Patanase
How this form is used
What it may be used for
  • Patanase and olopatadine hydrochloride nasal spray are indicated for relief of seasonal allergic rhinitis symptoms in adults and children 6 years of age and older
  • Safety and effectiveness in children under 6 years of age have not been established
Important instructions
  • Administer by the nasal route only — do not swallow or use in the eyes
  • Prime the nasal spray before first use and again if it has not been used for more than 7 days
  • Adults and adolescents 12 and older: 2 sprays per nostril twice daily; children 6 to 11 years: 1 spray per nostril twice daily — follow your prescriber's instructions
  • Avoid alcohol and other sedating medications while using the nasal spray; do not drive or operate machinery until you know how it affects you
Available strengths 3 strengths
600 mcg 665 mcg 665 mcg/100uL
18 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 3 strengths
1 mg/mL 2 mg/mL 7 mg/mL
6 FDA-listed product records ⓘ

📊 Olopatadine across the U.S. market

How Olopatadine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3
Dose forms ⓘ
74
Manufacturers
24
Brand names
246
FDA-listed product records ⓘ
1996
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Dr. Reddy's Laboratories Inc.8%
Apotex Corp.5%
A-S Medication Solutions4%
Target Corporation4%
Alcon Laboratories, Inc.4%
Aurohealth LLC4%
Other makers69%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Olopatadine is used

A general measure of how commonly Olopatadine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Olopatadine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

588,951
Medicaid prescriptions filled (Q1–Q4 2025)
$10.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Olopatadine prescribed? Of the 1,596 medications we measure, Olopatadine ranks #242 by Medicaid prescriptions — more than 85% of them.

Where Olopatadine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #242 of 1,596
#237 Valsartan 609,824 Rx #238 Testosterone Injection 605,127 Rx #239 Acetaminophen and Code... 601,646 Rx #240 Drospirenone / Ethinyl... 601,035 Rx #241 Ciprofloxacin and Dexa... 600,153 Rx #242 Olopatadine 588,951 Rx #243 Ethinyl Estradiol / No... 587,481 Rx #244 Clozapine 587,393 Rx #245 Ipratropium 583,555 Rx #246 Benzoyl Peroxide Topic... 583,362 Rx #247 Benzoyl Peroxide 583,362 Rx

Utilization by Olopatadine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg/mL ophthalmic solution is the most-dispensed Olopatadine product — about 47% of these Medicaid prescriptions.

olopatadine 1 MG/ML Ophthalmic Solution Most dispensed

276,737 Medicaid prescriptions (Q1–Q4 2025) 47% of Olopatadine prescriptions shown $4.2M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 12 of 65 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1111339

olopatadine 2 MG/ML Ophthalmic Solution

249,543 Medicaid prescriptions (Q1–Q4 2025) 42% of Olopatadine prescriptions shown $4.8M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 11 of 81 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1111343

olopatadine 7 MG/ML Ophthalmic Solution

41,148 Medicaid prescriptions (Q1–Q4 2025) 7% of Olopatadine prescriptions shown $875,934 gross reimbursement (before rebates) ≈ $21 per prescription (gross)

Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1601086

olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal Spray

21,523 Medicaid prescriptions (Q1–Q4 2025) 4% of Olopatadine prescriptions shown $813,934 gross reimbursement (before rebates) ≈ $38 per prescription (gross)

Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797895

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Olopatadine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 28 of 171 listed Olopatadine NDCs with Medicaid activity.

🔍 Compare Olopatadine products

A representative set of FDA-listed product records for Olopatadine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 246 products — FDA National Drug Code Directory. See every product, package size and price: browse all 246 Olopatadine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Olopatadine RxCUI 135391 2 dose forms · 4 strengths
  1. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797894 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 0.665 MG/ACTUAT RxCUI 1797895
  2. Dose form (SCDF) Ophthalmic Solution RxCUI 384613 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 1111339 2 MG/ML RxCUI 1111343 7 MG/ML RxCUI 1601086

Look up RxCUI 135391 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Pataday Patanase Eye Allergy Itch Relief Eye Allergy Itch and Redness Relief Pataday Once Daily Relief CVS Eye Allergy Itch Relief Pataday Twice A Day Relief Once Daily Relief Eye Allergy Itch Relief Once Daily Relief Allergy Relief Eye Drops Olopatadine Hydrochloride Ophthalmic Solution Twice Daily Olopatadine Hydrochloride Ophthalmic Solution Once Daily Leader Olopatadine Hydrochloride Ophthalmic Solution Retaine Allergy Leader Olopatadine Hydrochloride Eye Allergy Itch and Redness Relief Twice Daily Relief

🏭 Manufacturers & labelers

Dr. Reddy's Laboratories Inc. 17 Apotex Corp. 11 A-S Medication Solutions 9 Target Corporation 9 Alcon Laboratories, Inc. 8 Aurohealth LLC 8 Rite Aid Corporation 8 Rugby Laboratories 8 Gland Pharma Limited 8 Akorn 7 Chain Drug Marketing Association INC 7 Walgreens Company 6 Golden State Medical Supply, Inc. 6 CVS Health Corp 6 Strategic Sourcing Specialists, LLC 6 Alembic Pharmaceuticals Inc. 6 Strategic Sourcing Services LLC 5 Bryant Ranch Prepack 5 Dolgencorp, Llc 4 Cardinal Health 4 Somerset Therapeutics, LLC 4 Amerisource Bergen 4 Cardinal Health 110, Llc. Dba Leader 3 Walgreen Company 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Olopatadine belongs to the Histamine-1 Receptor Inhibitor class.

Pharmacologic class Histamine-1 Receptor Inhibitor, Histamine-1 Receptor Antagonist, Mast Cell Stabilizer
Drug family (ATC) Antiallergic agents, excl. corticosteroids, Other antiallergics
How it works Histamine H1 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 25, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Olopatadine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Olopatadine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
114
NDC products indexed
246
Distinct labelers/manufacturers represented
74
Linked representative label ⓘ
Somerset Therapeutics, LLC
Linked label effective
Mar 25, 2024
Composite sections available
24
Linked SPL Set ID
55142e80-c5db-46a5-85a5-e8a040bcc8cf
Linked SPL Document ID
9cb75ee7-d7e0-4f19-8088-05426d8ea407
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 114 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Somerset Therapeutics, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.